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Purpose: The emergence of multidrug-resistant (MDR) Gram-negative bacterial infections in the neonatal intensive care unit (NICU) is a major public health threat. Ceftazidime-avibactam (CAZ-AVI) provides a new option for treating infections caused by most beta-lactamase- and carbapenemase-producing Gram-negative bacteria in infants older than three months. However, treatment options are extremely limited, with no safety data available for preterm neonates. Here, we describe our experience regarding the safety and efficacy of off-label use of CAZ-AVI in a NICU in Brazil. Summary: We report a case of a premature infant (born at 29 weeks gestational age) treated with CAZ-AVI due to a bloodstream infection caused by MDR Klebsiella pneumoniae. Conclusion: Treatment with CAZ-AVI was safe and effective in our patient. [ABSTRACT FROM AUTHOR]

Background: Community pharmacists can help fight antimicrobial resistance by intervening in children's antibiotic prescriptions for upper respiratory tract infections (URTIs). However, caregivers' attitudes and perspectives on this are unknown. Objective: To evaluate children's caregivers' acceptability of pharmacists intervening in their antibiotic prescriptions for URTIs with respect to their knowledge of and attitude toward pharmacists and knowledge, beliefs, and behaviors related to antibiotics. Methods: A 69-item survey was created and sent to a panel of caregivers. ANCOVA and path analysis were used to evaluate the relationship between caregiver characteristics and their acceptability of pharmacists intervening in children's antibiotic prescriptions for URTIs. Results: Responses from 246 caregivers who met the inclusion and exclusion criteria were analyzed. Mean caregivers' acceptability of pharmacists intervening in children's antibiotic prescriptions for URTIs was 3.25 out of 5 (±1.01). The ANCOVA model (adjusted R2 =.636) showed positive attitude toward pharmacists and being more accepting of health advice from pharmacists since the start of the COVID-19 pandemic were associated with higher caregiver acceptability of pharmacists intervening in children's antibiotic prescriptions. Caregivers with better relationships with their pharmacist also tend to have better attitudes toward pharmacists. Not wanting antibiotics for symptom relief was associated with decreased acceptability scores. Conclusion: Overall caregiver acceptability of pharmacists intervening in antibiotic prescriptions was slightly above neutral. Building a relationship with caregivers could help change their attitude and increase the acceptability of pharmacists intervening in children's antibiotic prescriptions. Caregivers seeking symptomatic relief may be more open to non-antibiotic alternatives. [ABSTRACT FROM AUTHOR]

Introduction: Allogeneic Hematopoietic Stem Cells Transplantation (allo-HSCT) is capable of curing patients with neoplastic or non-neoplastic hematologic disorders or of prolonging their survival. This study assessed if the insertion of the clinical pharmacist in the allo-HSCT team modified the outcomes: transplantation-related mortality, grafting failure, incidence of Graft versus Host Disease, hospitalization time, time for grafting, number of readmissions, number of drug-related problems (DRPs), adherence and knowledge about pharmacotherapy. Methods: Interventional study with historical control carried out in an allo-HSCT unit, in which the intervention group (IG) included 33 individuals who received pharmacotherapy follow-up. Control Group (CG) consisted of 28 individuals. Results: A total of 250 DRPs were identified, 59 team's doubts were clarified, and 309 interventions were conducted in the IG. The DRPs mainly arose from safety (51.60%) and effectiveness (38.40%) problems. A mean of 9.36 (SD = 6.97) interventions per patient was obtained, mainly including dose reductions (19.09%), adjustments in administration time (18.12%), educational activities (15.21%) and drug removal (10.68%). Clinical significance of the interventions was considered high (75.7% extremely significant, very significant or significant), as well as their acceptability (89.7% accepted). Each patient attended a mean of 4.68 pharmaceutical consultations (SD = 1.91) after hospital discharge, presenting increase in knowledge (p = 0.0001) and in adherence (p = 0.0115). There was no evidence of differences between the groups in the other outcomes analyzed. Conclusions: The pharmacotherapy follow-up allowed detecting several DRPs and performing interventions of high clinical relevance and acceptability, in addition to improving adherence and individualizing the pharmacotherapy. [ABSTRACT FROM AUTHOR]

Background: While drug-related problems (DRPs) have been recognized as a major concern in pediatric wards, the role of hospital pharmacy in improving medication safety has been rarely studied. Objectives: To investigate the frequency, nature, and severity of DRPs and associated pharmacist interventions (PIs). Methods: This is a prospective study carried out using direct observation over a year (2019-2020) in 3 pediatric wards (pediatric emergency department (PED), pediatric intensive care unit (PICU), and neonatal intensive care unit (NICU) in Jazan, Saudi Arabia. A validated data reporting form was developed to include comprehensive clinical data about the prescribed medications, characteristics of patients, and PIs upon DRPs. Clinical significance of DRPs was evaluated by an expert panel, which comprised a clinical pharmacist, a pediatrician, and an internist. Data analysis was conducted using SPSS V26. Results: The overall incidence of DRPs was 6.6%. The highest rate of DRPs 15.2% was detected in the pediatric ICU. Of the 596 DRPs detected, 10.2% were inappropriate drug choice, 5.2% were rated major DRPs, and one-third 33.2% were related to the digestive system and metabolism. Dosing problems were the most predominant DRPs across the included wards. A higher proportion of clinically major and moderate DRPs were detected in pediatric ED. Telephone-delivered interventions [OR: 1.72: 95%CI: 0.78-2.57: P =.001], too high dose [OR: 2.64: 95%CI: 1.33-4.56: P =.01], and major DRPs [OR: 3.21: 95%CI: 2.15-6.42: P =.04] were significant predictors for acceptance of PIs. Conclusion: DRPs are common in Saudi pediatric wards and many of these incidents were clinically major and moderate. Telephone-delivered interventions, too high dose, and major DRPs were major predictors for physician acceptance of PIs. [ABSTRACT FROM AUTHOR]

Objective: Prescribing a drug for a child is not an easy task and requires using the best available evidence as a guide, especially when a drug is used off-label. The practice of prescribing a drug for off-label use is fairly widespread worldwide. The FDA does not regulate prescribing patterns or practices of individual practitioners and, therefore, allows off-label use. The main objective of this study is to evaluate off-label prescribing among the pediatric population in the Kingdom of Saudi Arabia (KSA). Method: This is a retrospective, simple random selection observational study of children (≤15 years) who visited pediatric clinics and had at least 1 drug prescribed over a 12-month period (January to December 2018). Results: A total of 865 drugs (mean 1 and SD 0.24) were prescribed to 326 children. Off-label was identified in 39.4% of the drugs with a frequency of 512 (as 1 drug may belong to more than 1 off-label category). The most common reason for off-label prescribing was related to doses that were "higher or lower than the recommended use" (48.6%), and the most frequently identified drug class prescribed for off-label use was anti-infective drugs for systemic use (39.9%). The percentage of off-label drug use was found to be higher in girls and in the age group of 1 month to 2 years (P =.001) for both variables. In addition, a significant association was found between off label drug use and the total number of drugs prescribed, P <.001. Conclusion: The findings of this study showed a high incidence of off-label prescribing mainly related to dosing and indication. The results of this observational study support the need to establish a unified national pediatric dosing formulary guide to ensure safe drug use in pediatrics. [ABSTRACT FROM AUTHOR]

Background: Oncology and hematology is a complex and specific area that requires monitoring by a multidisciplinary team capable of personalizing the treatment of each patient. Clinical pharmacy services have the potential to contribute significantly to the effective and economical care of cancer patients. Objective: To evaluate, synthesize and critically present the available evidence on the impact of the Clinical Pharmacy in the treatment of patients with hematological cancer. Method: A review was carried out on the bases PubMed/MEDLINE, LILACS and Google Scholar. The included studies were: studies that evaluated the effects of pharmaceutical interventions in clinical in oncology and hematology services and having as a population patient with hematological cancer. Results: 17 studies were selected among 745 identified. 4.771 patients were included, with an average follow-up time of 15.3 months. Patients affected by some type of hematological cancer, undergoing chemotherapy treatment, showed better adherence and continuity when accompanied by a clinical pharmacist, added to this professional in carrying out interventions, provides control of symptoms such as cancer pain, nausea and constipation and, thus, contributes to decrease the length of hospital stay. Conclusion: The implementation of a Clinical Pharmacy service in oncology and hematology centers contributes significantly to the effectiveness of pharmacotherapeutic treatment, treatment costs reduction, safety increase in the use of medications and the patient's quality of life. [ABSTRACT FROM AUTHOR]

Aims The goal of the present review was to identify studies that assess how pharmaceutical services contribute to hematopoietic stem cell transplantation (HSCT). Methods We conducted a systematic literature review of published studies describing results from clinical services provided by pharmacists working with HSCT, conducted according to PRISMA guidelines (PROSPERO registration number CRD42017062391). A search strategy was applied within PubMed, CENTRAL, EMBASE, SCOPUS, and LILACS databases in April 2017. Inclusion criteria were observational or experimental studies that addressed the following research question: "What are a clinical pharmacist's main contributions to HSCT?" The quality of selected studies was evaluated using the Downs and Black checklist. Results We identified 1838 studies, and seven were included in the systematic review. The results indicated that clinical pharmacy is useful during HSCT treatment within both inpatient and outpatient settings. Pharmaceutical contributions identified included management of pharmacotherapy-related problems, participation in discussions with clinical teams, drug reconciliation, patient and team education regarding pharmacotherapy, preparation of guidelines and educational materials, and evaluation of medication adherence. These activities favored the control and prevention of pharmacotherapy-related problems, the maintenance of immunosuppressive serum levels, improvement in patients' clinical and nutritional status, facilitated medication adherence, and provided economic and humanistic gains. Conclusions Despite the small number of articles discussing the topic under analysis, the results were unanimous in confirming the positive impact of pharmacists' contributions to clinical practice for HSCT. [ABSTRACT FROM AUTHOR]

Background: Breastfeeding is a major public health issue in terms of its benefits to both mothers and infants. Despite recommendations, breastfeeding initiation and duration are low in many industrialized countries. Although human milk is viewed as the most appropriate food for infants, when it is perceived as contaminated, doubts about its quality can lead to negative behaviors concerning breastfeeding. This is especially true when mothers are taking medication. Research aim: The aim of this review is to evaluate the data in the literature on the knowledge, representations, attitudes, and behaviors of women with regard to taking medication while breastfeeding. These elements should aid our understanding of how the mothers’ behaviors are constructed in this situation. Methods: The authors conducted a scoping review to map and analyze the available data from literature sources regarding breastfeeding mothers’ knowledge, representations, attitudes, and behaviors about medicines. A staged approach to the scoping review was used. Results: Eighteen studies met the selection criteria. They described safety behaviors like noninitiation, duration reduction, breastfeeding cessation, and refusal to take medication in order to breastfeed. Most showed a conflict between taking medication and breastfeeding. Because the knowledge, representations, and attitudes behind such behaviors have received very little study, it is difficult to explain how these behaviors are constructed. Conclusion: The results of this review confirm the need for a qualitative study to explore the knowledge, representations, and attitudes of breastfeeding women faced with taking medications, so that we can understand their connection with observed behaviors and take appropriate educational action. [ABSTRACT FROM AUTHOR]

When pharmacists incorporate clinical practice into their routine, barriers and facilitators influence the implementation of patient care services. Three focus groups were conducted with 11 pharmacists who were working for the Farmácia Popular do Brasil program on the establishment, implementation, and consolidation of clinical pharmacy services. The perception of the pharmacists in Brazil about the program was that it facilitated access to health care and medication. The distance between neighboring cities made it difficult for patients to return for services. Lack of staff training created a lack of communication skills and knowledge. The pharmacists wanted to have increased technical support, skill development opportunities, and monitoring of researchers who assessed progress of the service. Pharmacists overcame many of their insecurities and felt more proactive and committed to quality service. Positive experiences in service implementations have shown that it is possible to develop a model of clinical services in community pharmacies. [ABSTRACT FROM AUTHOR]

Objectives The aim of this study was to compare environmental contamination of cyclophosphamide (CP) during 1 week of drug compounding by conventional manual procedure in a biological safety cabinet (BSC) with laminar airflow and a new robotic drug preparation system (APOTECAchemo). Methods During four consecutive days, similar numbers of infusion bags with cyclophosphamide were prepared with both techniques in a cross-over design. Wipe samples (49 for BSC, 50 for APOTECAchemo) were taken at several locations (gloves, infusion bags, trays, BSC-benches, floor) in the pharmacy and analyzed for CP concentrations by GC-MSMS (LOD 0.2 ng/sample). Results The detection rate was 70% in the BSC versus 15% in APOTECAchemo. During manual preparation of admixtures using BSC contamination with CP was below 0.001 ng/cm2 at most locations, but significant on gloves (0.0004–0.0967 ng/cm2) and the majority (70%) of infusion bags (<0.0004–2.89 ng/cm2). During robotic preparation by APOTECAchemo, gloves (1 of 8: 0.0007 ng/cm2) and infusion bags (3 of 20: 0.0005, 0.0019, 0.0094 ng/cm2) were considerably less contaminated. Residual contamination was found on the surfaces under the dosing device in the compounding area (0.0293–0.1603 ng/cm2) inside the robotic system. Conclusions Compared to outcomes of other studies, our results underline good manufacturing procedures in this pharmacy with low contamination for both techniques (BSC and APOTECAchemo). Comparison of both preparation procedures validated that contamination of infusion bags was much lower by using the robotic system. [ABSTRACT FROM AUTHOR]

Objective. To describe environmental contamination with hazardous drugs in a hospital pharmacy setting before and after reorganizing a hematology-oncology satellite pharmacy. Methods. This is a descriptive study of surface contamination with cyclophosphamide, ifosfamide, and methotrexate in two hematology-oncology satellite pharmacies. In order to measure surface contamination with hazardous drugs, samples from four distinct measurement sites within the pharmacy were taken in each of the two phases (pre- and postphases) using a sampling procedure and an analytical method modified from Larson et al. Results. A total of 133 samples from four measurement sites were taken and analyzed over the course of the study (specifically 60 prephase samples and 73 postphase samples). The study showed a significant increase in the number of positive samples (from 66.7% to 90.4%, p<0.001) from the pre- to the postphase. The increase, however, is only significant in terms of the location where completed preparations were placed after they had come out from under the hood (from 0/15 to 21/28, p<0.001) and the work surface (from 8/15 to 15/15, p = 0.006) and only in terms of ifosfamide. Furthermore, for the other sites studied, the number of positive samples remained unchanged between the pre- and postphase. A statistically significant difference between the pre- and postphase was observed in terms of ifosfamide for three of the four measurement sites studied and methotrexate for one of the four sites. Average concentrations were higher in the post phase in three of the four cases. Conclusion. This study describes environmental contamination with hazardous drugs in a hospital pharmacy setting before and after reorganizing a hematology-oncology satellite pharmacy. The study showed that a refitting of the hemato-oncology pharmacy is not a sufficient strategy to reduce the environmental contamination by ifosfamide because a significant increase in the number of positive samples from the pre- to the postphase have been observed. Many factors can contribute to influence the contamination of hazardous drugs such as the workflow and the training of the personal. Continuous environmental surveillance of hazardous drugs is required to document traces and help reduce risks. [ABSTRACT FROM AUTHOR]

Introduction. Hematopoietic stem cell transplant patients represent a population at high risk for drugrelated problems. Our objective is to describe pharmacist interventions in a hematopoietic stem cell transplant pediatric unit. Methods and Patients. The Hematopoietic Stem Cell Transplant Unit of the Centre Hospitalier Universitaire Sainte-Justine performs around 50 hematopoietic stem cell transplants per year. During a pharmaceutical care specialized residency program, a French pharmacist participated in certain clinical activities. Drug-related problems and clinical interventions were compiled over 31 nonconsecutive days using a tool developed by the Société Française de Pharmacie Clinique. Data concerning patients, drugs, intervention, documentation, approval (if needed), and estimated impact were compiled. Results. During the 31-day period, 525 interventions were collected (16.9±3.7 per day), targeting 29 patients. The main drug-related problems were adverse drug reactions (N=125, 23.8%), untreated indication (N=92, 17.5%) and failure to receive drug (N=89, 17.0%). The pharmacist's interventions concerned mainly dose adjustment (N=174, 33.1%) and drug monitoring (N=132, 25.1%). Among the 324 (61.7%) interventions requiring a physician's approval, 302 (93.2%) were accepted without any change. Conclusion. A pharmacist is able to perform clinically relevant interventions in a hematopoietic stem cell transplant unit, given the complexity of the pharmacotherapy. Our description of drugrelated problems and interventions may help other pharmacists already working or developing pharmaceutical care in a hematopoietic stem cell transplant unit to compare their practice and it is one of the few reported in the literature. [ABSTRACT FROM AUTHOR]